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ADV/HSV-tk · 1 trial · 2 indications
The objective response rate (ORR) of ADV/HSV-tk plus (+) valacyclovir therapy in combination with SBRT used as a window of opportunity treatment before pembrolizumab in patients with metastatic TNBC and metastatic NSCLC. Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 will be used to assess treatment response. Modified immune-related response criteria (irRC; derived from RECIST 1.1) will also be documented.
| Arm | Type | Description |
|---|---|---|
| Single arm | EXPERIMENTAL | ADV/HSV-tk (5 x 1011 virus particles) in a 2-mL total volume will be injected intratumorally on Day 0. Valacyclovir will be orally administered at a dose of 2 g three times daily for 14 days from Day 1 to Day 15. SBRT of 30 Gy (6 Gy X 5 fractions) will be administered over 2 weeks from Day 2 to Day 16. Pembrolizumab (200 mg) will be administered intravenously over 30 minutes every 3 weeks starting on Day 17 and continuing until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. |
| Name | Type | Description |
|---|---|---|
| ADV/HSV-tk | BIOLOGICAL | Replication-defective recombinant adenovirus vector |
| Valacyclovir | DRUG | Prodrug of the antiviral drug acyclovir |
| SBRT | RADIATION | Low-dose SBRT |
| Pembrolizumab | DRUG | Humanized immunoglobulin G4 anti-programmed death-1 (PD-1) monoclonal antibody |
Inclusion Criteria: 1. Willing and able to provide written informed consent/assent for the trial. 2. Male or female aged ≥18 years on the day of informed consent signing. 3. Histologically confirmed locally advanced or metastatic TNBC that has relapsed on or is refractory to standard of care therap...
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ADV/HSV-tk is an investigational oncolytic virus therapy being studied for the treatment of metastatic non-small cell lung cancer. It is administered in combination with stereotactic body radiation therapy (SBRT) and pembrolizumab. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
ADV/HSV-tk is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy in patients with metastatic non-small cell lung cancer.
ADV/HSV-tk is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies such as the FDA. The drug is being studied in a completed Phase 2 trial that enrolled 57 patients with metastatic non-small cell lung cancer and metastatic triple-negative breast cancer.
ADV/HSV-tk has been studied in one clinical trial registered as NCT03004183, titled "SBRT and Oncolytic Virus Therapy Before Pembrolizumab for Metastatic TNBC and NSCLC." This Phase 2 trial was conducted in the United States and has been completed. The study enrolled 57 participants and was not randomized or double-blinded.
Yes, ADV/HSV-tk is an oncolytic virus therapy. It is designed to selectively infect and destroy cancer cells while sparing normal cells. In the clinical trial, it was administered in combination with stereotactic body radiation therapy (SBRT) and the immunotherapy drug pembrolizumab to treat metastatic non-small cell lung cancer.